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Pelvic Ultra-Hypofractionated Adjuvant Radiotherapy for Endometrial Cancer (PURE-cohort)

RecruitingNAAges 18 Years - 110 YearsFemaleInstituto de Investigación Sanitaria Aragón
NCT07779109 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The PURE trial is a prospective multicenter phase II study evaluating the safety and feasibility of ultra-hypofractionated adjuvant pelvic radiotherapy in patients with high-intermediate-risk and high-risk endometrial cancer following surgery. The study investigates a treatment regimen consisting of 27.5 Gy delivered in five fractions using modern image-guided IMRT/VMAT techniques. The primary objective is to assess acute gastrointestinal and genitourinary toxicity according to CTCAE version 5.0.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged \> 18 years. 2. Histologically confirmed diagnosis of endometrial cancer post hysterectomy: endometrial adenocarcinoma, serous or clear cell carcinoma, or carcinosarcoma or dedifferentiated carcinoma. 3. Patients candidates for adjuvant pelvic (Cht)EBRT treatment (+/- vaginal cuff brachytherapy), categorized by Intermediate-high risk and high risk primary endometrial cancer based on recent ESGO/ESTRO/ESMO Guidelines (2025). 4. Patient is willing and able to give informed consent to participate in this clinical trial. 5. Patient must be willing and able to complete the QLQ-C30 questionnaire with EN-24 companion as described in the study protocol 6. Possibility of fiducial marker placement on vaginal vault. 7. Dosimetric feasibility based on OAR constraint and targets objective Exclusion Criteria: 1. Prior pelvic or abdominal radiation therapy delivered. 2. Inflamatory bowel disease of other contraindication to pelvic radiotherapy. 3. Previous abdominal or pelvic complicated surgery.
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What it tests

  • Ultra-hypofractionation schedule of 27.5Gy in 5 fractions on image-guided adjuvant pelvic IMRT/VMAT radiotherapy
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Where

1 site
Unidad Clínica Multihospitalaria de Oncología Radioterápica de Aragón (UCMORA)
Zaragoza, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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